Customers often ask us if Pixie Cup is FDA Approved. In this post, we’ll chat about the ins and outs including what FDA Approval actually means.
The Food and Drug Administration is responsible for telling us which foods, drugs, and medical devices are safe for us to use. And while we assume that anything that’s been cleared or approved by the FDA has been rigorously tested, that’s not always true. We value transparency and want to debunk myths by outlining everything between the FDA and menstrual cups!
What is FDA Approval?
FDA Approval happens (or doesn’t happen) when a company registers their product with the FDA. A mountain of paperwork is submitted, and the FDA conducts rigorous inspections of concept, manufacturing, ingredients, and materials.
“FDA approved” means that the agency has determined that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.
What does the FDA regulate?
For the most part, the Food and Drug Administration evaluates the safety of:
- Prescription drugs for humans and animals
- Over-the-counter drugs
- Biologics (e.g. vaccines, blood products, biotechnology products)
- Dietary supplements (not all are subject to FDA regulation)
- Medical devices (everything from menstrual cups to pacemakers)
- Surgical implants
- Food additives
- Products that give off radiation (e.g. X-rays, microwave ovens)
- Tobacco products
- Infant formula
What about menstrual cups?
The FDA allows companies to piggyback off other concepts if they can prove their product does the same job as a competitor and that the manufacturing, packaging, and ingredients are FDA Approved; this is called FDA Cleared. [or 501(k)] Menstrual cups are considered a Class II medical device, meaning it is inserted into the body but doesn’t aid or perform surgery or sustain life.
FACT: No menstrual cup on the market has been officially FDA Approved.
Most of them are officially FDA Cleared, however. Let’s take a quick look at how the Food & Drug Administration regulates tampons, pads, and menstrual products in general.
As the rise for health and wellness continues in recent years, women are seeking out more information about what exactly goes into our bodies. (yay for us!) And with that, we’ve started to question what’s in tampons and pads. An article in the New York Times hits the topic hard. Because up to this point, the FDA doesn’t require manufacturers to put ingredients on the packaging of disposable menstrual products. There is currently a bill in legislation about transparency in tampons + pad ingredients.
If you’re curious as to what’s actually been found in mainstream tampons and pads, our friends at MadeSafe have put together all the specifics.
Is Pixie Cup FDA Approved?
We have gone above and beyond to make sure our manufacturers maintain a level of safety and excellence. They undergo annual unannounced inspection and audit to ensure quality and safety standards are still in place. We, at Pixie Cup, are the specification developers and have to complete the application process to be FDA Cleared for sale in the USA. Our manufactures and packagers also have to be FDA Approved. The approval process for them is more rigorous as their facilities have to maintain FDA standards.
Here at Pixie Cup, we only use medical-grade silicone. Medical grade silicone is approved by the FDA for its biocompatibility, which means it’s safe to be inserted inside the body without any risks. So while the cup itself may not be FDA Approved, the material we use is. The medical-grade silicone that we use for our Pixie Cups is hypoallergenic and latex-free, so it’s safe for people with latex allergies. Silicone is also non-porous, which means that it’s resistant to bacterial growth. That being said, it’s still extremely important to make sure that you keep your cup as clean as possible and wash it every time you use it.
When using your menstrual cup regularly, be sure to maintain cleanliness and sterilize your cup appropriately and regularly so it’s the best condition possible! If you’re new to using a menstrual cup, you will soon realize all the benefits and freedom that comes along with them!
We’re in this together.
Here at Pixie Cup, everything we do is geared towards making an impact for the better. Every time someone purchases a Pixie Cup, we donate one to a woman in need through our Buy One, Give One program.
On top of that, we care about YOU too! We care about your satisfaction and that’s why we have our 100% Happiness Guarantee. If for any reason you aren’t totally thrilled with your PIxie Cup purchase, we will refund you. Along with that is our transparency — please feel free to contact us regarding any questions you may have. We’re here to help!
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